By Kelly M. Pyrek
Editor's note: This article originally appeared as part of the 2012 Regulatory Update in the January 2012 print issue of ICT. To access a slide show presenting the highlights of the 2012 Regulatory Update, CLICK HERE.
Reprocessing medical devices is an intricate, complicated task, and lapses in infection prevention practices can lead to poor patient outcomes and infections. Cognizant of these implications and the role that medical device preprocessing plays in the larger healthcare arena, last summer the Food and Drug Administration (FDA) launched a coordinated effort focusing on improvements in device design, reprocessing procedures and validation methodologies, and healthcare facility quality assurance practices. In June 2011, the FDA's Center for Devices and Radiological Health (CDRH) held a two-day public workshop, and in October 2011, the FDA and the Association for the Advancement of Medical Instrumentation (AAMI) held a joint two-day summit -- all with the express purpose of discussing factors affecting the quality of reprocessing of reusable medical devices and then soliciting public comment, sharing information and experiences and defining an agenda for the work to follow.
These events are part of the FDA's ongoing effort to address patient exposure to inadequately reprocessed reusable medical devices with the overall goal to reduce the risk of infection. (This effort focuses on medical devices that are intended for reuse after reprocessing and does not include third-party reprocessing of single-use-only medical devices.)
It's a timely effort, judging by the continuing news of outbreaks related to improperly cleaned, disinfected and sterilized surgical instruments, as well as the FDA's receipt of a number of reports of patient exposure to inadequately reprocessed medical devices and subsequent healthcare-associated infections (HAIs). Several reports contained evidence suggesting that inadequate reprocessing may have been a contributing factor in microbial transmission and subsequent infection. The FDA says that, "A definitive causal relationship between reusable device reprocessing and any patient infection is difficult to establish, because inadequate reprocessing is not often investigated as a cause when an HAI is diagnosed. Ensuring adequate reprocessing of reusable medical devices could reduce the incidence of HAIs associated with the use of a reprocessed medical device. This will decrease the public health burden of HAIs in terms of morbidity, mortality and cost."
The FDA adds that, "The adequate reprocessing of reusable medical devices is a critically important factor in protecting patient safety. Inadequate reprocessing between patients can result in the retention of blood, tissue and other biological debris (soil) in reusable medical devices. This soil can allow microbes to survive the high level disinfection or sterilization process, potentially resulting in Healthcare-Associated Infections (HAIs) or other adverse patient outcomes."
The agency has been informed about problems in all steps of medical device reprocessing, including cleaning, disinfecting and sterilizing, and says that manufacturers, healthcare facilities, healthcare professionals, and the FDA all have a role in reducing the risk of inadequately reprocessed medical devices. These very stakeholders have been coming together recently to discuss a number of key points, including:
- The nature, scope and impact of reusable medical device reprocessing problems that have been observed and the causes of these problems
- Factors which facilitate reprocessing that should be considered when designing reusable medical devices and how the design process can be improved to better incorporate cleanability as a design endpoint
- Criteria that should be considered when developing reprocessing instructions and validation protocols for devices to be used in various healthcare environments, based on the draft guidance document, "Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling"
- Factors that should be considered by a healthcare facility when developing reusable device reprocessing procedures and quality assurance processes
- How problems with reusable medical device reprocessing should be identified, reported and acted upon by industry and users
At the June 2011 workshop, Michelle McMurry‐Heath, associate center director for science at the FDA, explained that, "FDA has received scattered reports of improperly cleaned reprocessed medical devices. We particularly noticed difficulty in cleaning some endoscopes, arthroscopic shavers, and reusable devices with specific design features such as lumens, hinges, interior channels, and devices that cannot be easily disassembled, so we took action."
McMurry‐Heath explained that in 2007, these reports led to an increased concern within the FDA after news about contamination of reprocessed endoscopes in the Veterans Affairs medical system surfaced. In 2008, the FDA collaborated with the VA and CDC to try to address these concerns. In 2009, the FDA issued two safety communications on reprocessed devices, one on endoscopes and one on arthroscopic shavers, and a VA conference on this topic was held. In April 2011, the FDA launched its initiative, the Reusable Medical Device Improvement Initiative, which was accompanied by new draft guidance, the aforementioned "Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."
